The REGARD Study – A Head-to-Head Comparison of Rebif®® (glatiramer acetate) 44 mcg (interferon beta-1a) and Copax
Posted Jan 15 2009 7:22pm
Initial information provided by Cherie Binns The trial cited here compared several hundred Rebif users and Copaxone users for 4 years finding that both meds are safe and effective.
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The results of the REGARD* study were presented at the recent 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The REGARD study compared Rebif (interferon beta-1a) 44 mcg and Copaxone (glatiramer acetate) over 96 weeks in patients with relapsing-remitting MS. Principal investigator, Daniel Mikol, MD, PhD, from the Department of Neurology at the University of Michigan, Ann Arbor, provides some first-hand insight into the findings of the study.
Q. What was the overall rationale for the REGARD study and what information were you hoping it would provide?
Dr Mikol: The REGARD study was the first well-controlled, randomized, head-to-head study between any interferon-beta and glatiramer acetate. The interferon-beta preparation used in the study was Rebif, and the study was sponsored by EMD Serono and Pfizer, co-marketers of Rebif in the US.
It's well accepted that the best way to gauge the relative efficacies of 2 agents in a disease such as relapsing-remitting MS is to compare them head-to-head. Prior to this study, the only way to try to compare interferon-beta and glatiramer acetate was by using results from the individual placebo-controlled studies — different trials with different patient populations, and trial designs that differed somewhat from one study to another. So in conducting the REGARD study, the intent was to use the same population of patients and the same study design to determine whether one agent was superior to the other.
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